UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	PET study of the density ratio of the serotonin 2A receptors and D2 receptors in the each subregions of the prefrontal cortex
Title of the study (Brief title)	PET study of the density ratio of the serotonin 2A receptors and D2 receptors in the each subregions of the prefrontal cortex
Region	Japan

Condition
Condition	Healthy
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the density ratio of the serotonin 2A receptors and D2 receptors in the each subregions of the prefrontal cortex.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The binding potential ratio of the serotonin 2A receptor Binding potential and D2 receptor Binding potential in the each subregions of the prefrontal cortex
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	PET/MRI/neuropsychological batteries/neurological examinations
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	40 years-old >
Gender	Male
Key inclusion criteria	20y.o.<=40<y.o.healthy male volunteers participated in the study Serotonergic system and subjective perception Healthy volunteers eligible for this study Healthy volunteers with ability to make informed consent
Key exclusion criteria	History of psychiatric diseases, sever physical diseases, neurological diseases Implanted metal or tatto in the body Claustrophobia Those who was considered to be inapptopriate to participate in the study
Target sample size	12

Research contact person
Name of lead principal investigator	Yasuyuki Kimura
Organization	National Institute of Radiological Sciences
Division name	Molecular Imaging Center
Address	4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL	81432063025
Email	y-kimura@nirs.go.jp

Public contact
Name of contact person	Tatsuya Ishii
Organization	National Institute of Radiological Sciences
Division name	Molecular Imaging Center
Address	4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL	81432063025
Homepage URL
Email	tishii@nirs.go.jp

Sponsor
Institute	National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization	National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 25 Day
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 04 Month 23 Day
Last modified on	2016 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016102